# K202445: Hystero-V Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Hysterovue, Inc.
- Decided: Nov 23, 2021 after 454 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 34 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132384: U-Scope 8000 System with HSC+Emb Cannula, Endosec Corporation (2014) Summary page 4.

## Most influential descendants
- K232003: Endoscopic Video Image Processor, Single-Use Video Hysteroscope (2024), 3 descendants of its own
- K240978: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) (2024), 1 descendant of its own
- K254294: Single-use Digital Hysteroscope (GYUT-A 12.6- 0,  GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30,  GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22,  GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12,  GYUT-B 15-22, GYUT-B 15- 30) (2026), 0 descendants of its own
- K241987: Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (2024), 0 descendants of its own

## Indications for use
The Hystero-V hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

Source page: https://510kreport.com/device/K202445
Methodology: https://510kreport.com/methodology